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Zoo or savannah? Choice of training ground for evidence-based pharmacovigilance
Stockholm University, Faculty of Science, Department of Mathematics. Uppsala Monitoring Centre, Sweden.
Stockholm University, Faculty of Social Sciences, Department of Computer and Systems Sciences. Uppsala Monitoring Centre, Sweden.ORCID iD: 0000-0002-2259-1716
2014 (English)In: Drug Safety, ISSN 0114-5916, E-ISSN 1179-1942, Vol. 37, no 9, 655-659 p.Article in journal (Refereed) Published
Abstract [en]

Pharmacovigilance seeks to detect and describe adverse drug reactions early. Ideally, we would like to see objective evidence that a chosen signal detection approach can be expected to be effective. The development and evaluation of evidence-based methods require benchmarks for signal detection performance, and recent years have seen unprecedented efforts to build such reference sets. Here, we argue that evaluation should be made against emerging and not established adverse drug reactions, and we present real-world examples that illustrate the relevance of this to pharmacovigilance methods development for both individual case reports and longitudinal health records. The establishment of broader reference sets of emerging safety signals must be made a top priority to achieve more effective pharmacovigilance methods development and evaluation.

Place, publisher, year, edition, pages
2014. Vol. 37, no 9, 655-659 p.
National Category
Public Health, Global Health, Social Medicine and Epidemiology
URN: urn:nbn:se:su:diva-107391DOI: 10.1007/s40264-014-0198-zISI: 000344615000001OAI: diva2:746760
Available from: 2014-09-15 Created: 2014-09-15 Last updated: 2014-12-16Bibliographically approved

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Norén, G. NiklasCaster, Ola
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